This disclosure relates to an apparatus and method for the biopsy of tissue specimens and, more particularly, to a driver apparatus for biopsy instruments.
It is often necessary to sample tissue in order to diagnose and treat patients suspected of having cancerous tumors, pre-malignant conditions and other diseases or disorders. Typically, in the case of suspected cancerous tissue, when the physician establishes by means of procedures such as palpation, x-ray or ultrasound imaging that suspicious conditions exist, a biopsy is performed to determine whether the cells are cancerous. Biopsy may be done by an open or percutaneous technique. Open biopsy removes the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). Percutaneous biopsy on the other hand is usually done with a needle-like instrument and may be either a fine needle aspiration (FNA) or a core biopsy. In FNA biopsy, individual cells or clusters of cells are obtained for cytologic examination and may be prepared such as in a Papanicolaou smear. In core biopsy, as the term suggests, a core or fragment tissue is obtained for histologic examination which may be done via frozen section or paraffin section. In more recent developments percutaneous techniques have been used to remove the entire mass during the initial procedure.
Intact tissue from the organ or lesion is preferred by medical personnel in order to arrive at a definitive diagnosis regarding the patient""s condition. In most cases only part of the tissue or lesion need be sampled. The portions of tissue extracted must be indicative of the tissue or lesion as a whole. In the past, to obtain adequate tissue from organs or lesions within the body, surgery was performed so as to reliably locate, identify and remove the tissue. With present technology, medical imaging equipment such as stereotactic x-ray, fluoroscopy, computer tomography, ultrasound, nuclear medicine and magnetic resonance imaging, may be used. These technologies make it possible to identify small abnormalities even deep within the body. However, definitive tissue characterization still requires obtaining adequate tissue samples to characterize the histology of the organ or lesion.
The introduction of image guided percutaneous breast biopsies offers alternatives to open surgical breast biopsy. With time, these guidance systems have become more accurate and easier to use. Biopsy guns were introduced for use in conjunction with these guidance systems. Accurate placement of the biopsy guns was important to obtain useful biopsy information because only one small core could be obtained per insertion at any one location. To sample the tissue thoroughly, many separate insertions of the instrument are often required.
Biopsy procedures may benefit from larger tissue samples being taken, for example, tissue samples as large as 10 mm across. Many of the prior art devices required multiple punctures into the breast or organ in order to obtain the necessary samples. This practice is both tedious and time consuming.
One further solution to obtain a larger tissue sample is to utilize a device capable of taking multiple tissue samples with a single insertion of an instrument. An example of such a device is found in U.S. Pat. No. 5,195,533 to Chin et al. which describes a technique for extracting multiple samples with a single insertion of the biopsy device. Generally, such biopsy instruments extract a sample of tissue from a tissue mass by either drawing a tissue sample into a hollow needle via an external vacuum source or by severing and containing a tissue sample within a notch formed on a stylet. Typical of such devices utilizing an external vacuum source are U.S. Pat. No. 5,246,011 issued to Cailouette and U.S. Pat. No. 5,183,052 issued to Terwiliger. Such devices generally contemplate advancing a hollow needle into a tissue mass and applying a vacuum force to draw a sample into the needle and hold the same therein while the tissue is extracted. These devices require an operator to manually perform some of the separate functions involved in extracting tissue samples. These functions, include, for example, translating the needle within a patient, actuating a cutting mechanism, and actuating a vacuum source.
When extracting multiple samples with a single insertion of the biopsy device using suction to either draw in tissue or remove the tissue from the body, it is important that reliable samples are extracted for accurate diagnosis. If the operator is required to frequently manipulate and adjust a device to accommodate the several functions, the reliability and integrity of the sample may be compromised.
Therefore, a continuing need exists for driver apparatus which can reliably introduce biopsy instruments to extract adequate biopsy sample(s) and reduce the number of operations required to be performed by an operator.
One particular embodiment of the present disclosure provides a surgical biopsy apparatus which includes a driver apparatus for use with a biopsy instrument which includes a plurality of relatively movable elongated members. The driver apparatus includes a housing, an insertion mechanism, a linear control mechanism and a tissue retract mechanism. The driver apparatus may be mounted to an imaging table and may also communicate with a vacuum/controller module.
The insertion mechanism includes a carriage that is movably associated with the housing. The carriage is adapted to support the biopsy instrument to affect longitudinal movement of at least a portion of the biopsy instrument relative to the housing.
The linear motion control mechanism is adapted to move a tissue cutting element of the biopsy instrument from a first position to a second position relative to a tissue receiving portion of the biopsy instrument. The tissue cutting element cuts tissue extending into a tissue receiving portion of the biopsy instrument.
The tissue retract mechanism facilitates removal of a tissue specimen from the biopsy instrument without removing the entire biopsy instrument from a surgical site. The tissue retract mechanism includes a retention member adapted to retain a portion of the biopsy instrument. The tissue retract mechanism further includes a longitudinal guide member which slidably guides the retention member and is disposed relative to the housing in a manner to permit movement of the longitudinal guide member relative to the housing.
In an alternate embodiment of the present disclosure, a surgical biopsy apparatus is provided which includes a driver apparatus for use with a biopsy instrument which includes a tissue receiving portion and a cutting element. The driver apparatus includes a housing, an insertion mechanism and a cutting element controller assembly. The insertion mechanism is adapted to support a biopsy instrument thereon. The insertion mechanism includes a carriage that is movably associated with the housing. The carriage is movable from a retracted position to an advanced position to affect longitudinal movement of the biopsy instrument. The cutting element controller assembly is operatively disposed on the housing. The controller assembly includes a linear motion control mechanism, a motor and an enabling switch.
The linear motion control mechanism is adapted to move a tissue cutting element of the biopsy instrument from a first position to a second position relative to a tissue receiving portion of the biopsy instrument. The tissue cutting element cuts tissue extending into a tissue receiving portion of the biopsy instrument.
The motor is operatively associated with the cutting element when the biopsy instrument is mounted on the biopsy instrument driver apparatus. The motor facilitates movement of the cutting element relative to the tissue receiving portion.
The enabling switch is disposed relative to the linear motion control member and electrically connected to the motor. Movement of the linear motion control member from the second position to the first position causes the switch to activate the motor.